Parallel Arm Trial of AD109 and AD504 In Patients With OSA

Phase 2 Randomized Double-Blind Placebo-Controlled Parallel-Arm Dose Finding Study to Compare Fixed Dose Combinations of AD109 and AD504 to Atomoxetine or Placebo in Obstructive Sleep Apnea

This is a phase 2 randomized double-blind placebo-controlled parallel-arm dose finding study to compare fixed dose combinations of AD109 and AD504 to atomoxetine or placebo in Obstructive Sleep Apnea.

Inclusion Criteria:

• Between 18 to 65 years of age for men and 18-75 for women, inclusive, at the Screening Visit.
• Mean AHI 10 to 45 events/h, inclusive
• PGI-S: >1
• BMI between 18.5 and 38 kg/m2 for men and 40 kg/m2 for women, inclusive.

Exclusion Criteria:

• Current clinically significant sleep disorder other than OSA
• Clinically significant craniofacial malformation.
• Clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery disease or heart failure or hypertension requiring more than 2 medications for control).
• Participants with a history of using devices for OSA treatment, including CPAP, oral or nasal devices, or positional devices, may enroll as long as the devices have not been used for at least 2 weeks prior to first PSG and are not used during participation in the study